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Roche Submits Application for Tecentriq-Avastin Combo in HCC
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Roche (RHHBY - Free Report) announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for the label expansion of immuno-oncology drug, Tecentriq (atezolizumab).
Roche is seeking approval of Tecentriq in combination with Avastin (bevacizumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC), who have not received prior systemic therapy.
The application was based on the results of the phase III IMbrave150 study.
The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which should result in an efficient review process to ensure the availability of safe and effective treatments for patients as early as possible.
In July 2018, the FDA granted Breakthrough Therapy designation to the combo for the above-mentioned indication, based on data from an ongoing phase Ib trial.
A potential label expansion in the promising HCC space will boost sales of the drug. HCC, the most common form of liver cancer, is an aggressive disease as more than 750,000 people worldwide are diagnosed with HCC every year.
Tecentriq is approved in the United States and the EU either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and PD-L1-positive metastatic triple-negative breast cancer. Roche has an extensive development program for Tecentriq, including multiple ongoing and planned phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. The program includes studies evaluating the drug as monotherapy as well as in combination with other drugs.
We note that Exelixis’ (EXEL - Free Report) Cabometyx is already approved for the treatment of HCC.
Roche’s shares have jumped 28.3% in the past year compared with the industry's 16.2% growth.
While the uptake of Tecentriq has been strong, it is currently facing stiff competition from immuno-oncology therapies like Merck’s (MRK - Free Report) Keytruda and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications.
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Roche Submits Application for Tecentriq-Avastin Combo in HCC
Roche (RHHBY - Free Report) announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for the label expansion of immuno-oncology drug, Tecentriq (atezolizumab).
Roche is seeking approval of Tecentriq in combination with Avastin (bevacizumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC), who have not received prior systemic therapy.
The application was based on the results of the phase III IMbrave150 study.
The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which should result in an efficient review process to ensure the availability of safe and effective treatments for patients as early as possible.
In July 2018, the FDA granted Breakthrough Therapy designation to the combo for the above-mentioned indication, based on data from an ongoing phase Ib trial.
A potential label expansion in the promising HCC space will boost sales of the drug. HCC, the most common form of liver cancer, is an aggressive disease as more than 750,000 people worldwide are diagnosed with HCC every year.
Tecentriq is approved in the United States and the EU either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and PD-L1-positive metastatic triple-negative breast cancer. Roche has an extensive development program for Tecentriq, including multiple ongoing and planned phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. The program includes studies evaluating the drug as monotherapy as well as in combination with other drugs.
We note that Exelixis’ (EXEL - Free Report) Cabometyx is already approved for the treatment of HCC.
Roche’s shares have jumped 28.3% in the past year compared with the industry's 16.2% growth.
While the uptake of Tecentriq has been strong, it is currently facing stiff competition from immuno-oncology therapies like Merck’s (MRK - Free Report) Keytruda and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications.
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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